To register medical devices in China, type testing is required. Whereas in the past, this testing needed to be done in China, China has now allowed for testing overseas. Given the long time it may take for type testing in China (anywhere from 3-9 months), this may prove helpful to some foreign device companies looking to register and export to China. On the other hand, Chinese regulators will have the right to closely check the foreign device companies’ QMS and testing standards, so how much of an advantage this will be may be unclear.
Accordingly, on September 16, China’s NMPA issued and implemented the “Guidelines for Self-inspection/Tests Verification of Medical Device Registration.” As mentioned above, when applying for device registration in China, foreign device manufacturers who have Class 2 and Class 3 devices can now conduct self-inspections overseas. Foreign device companies that will do self-tests need to integrate their processes into their QMS in line with GMP requirements for medical devices. Foreign device manufacturers need to ensure that their self-testing facilities meet specific requirements, they have an internal quality inspection team or full-time testing inspectors, and have strict controls.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.